A cataract is clouding of the lens of the eye, which impedes the passage of light. Most cataracts are related to ageing, but occasionally children are born with the condition; or the cataract may develop after an injury, inflammation, or disease. Risk factors for age-related cataracts include diabetes, prolonged exposure to sunlight, tobacco use, and excessive alcohol consumption.
Vision can be restored by surgically removing the affected lens, and in most cases replacing it by an artificial one. Indeed, in Western countries the rate of cataract surgery has increased significantly during the past two decades. In many countries, cataract surgery now accounts for over half of all ophthalmic surgery and has become the most common elective surgical procedure. Although today the removal of the opaque lens and its replacement with an artificial one represents a routine operation that involves only minor risks, it consumes a considerable share of the resources for ophthalmic care. Minimizing the side effects of cataracts procedures and impact of the health care system remains an important goal.
In addition to antibiotic eye drops to prevent infection, anti-inflammatory eye drops are also prescribed to help reduce any internal inflammation. These eye drops are in some cases started before surgery, and in some cases must be continued for 2 or 3 months. Compliance with dosing and application regimens in order to minimize the side effects of inflammation can be challenging for many patients. The quicker any inflammation is resolved the quicker the patient realizes the full desired therapeutic outcome of the surgery and can resume normal daily activities. Additionally, the use of eye drops to delivery medication into the eye is at best marginally effective. In most cases only a small percentage of the dose actually enters the eye. This factor along with compliance issues limit the effective drug levels that can be achieved using eye drop technology. Therefore, there is a need for sustained release anti-inflammation therapy that can benefit the cataract patient by replacing the need for anti-inflammatory eye drops. In particular, there is a need for a formulation and method that delivers highly effective drug levels without the issues associated with eye drops, which formulation results in superior clinical results.